 Even unexpected clinical trial results couldn’t derail this endovascular medical devices company for long.
Millions of people suffer from vascular blood clots annually. These clots, called thrombus, block circulation and can cause very serious, even fatal complications. One company, Possis Medical, is dedicated to bringing new thrombosis treatments into the healthcare industry, even after recovering from a blockage of its own.
 Bob Dutcher, CEO
“In essence we turn the small tube into a miniature vacuum cleaner,” said Bob Dutcher, CEO. “It allows a physician to quickly and safely remove blood clots and restore blood flow.”
Stroke of genius
Possis was not always a medical device company. It was created in 1952 and went public in 1960 as an industrial products company. Two decades ago, Dutcher was brought in to create a medical division. At the time, the company had industrial versions of water jet equipment, the type of equipment that uses highly pressurized water jets to cut concrete and steel, and was even used to cap burning oil wells in the Middle East. Dutcher saw an opportunity to bring the technology to bear in the medical market if it could be miniaturized. Since 1994, Possis has been exclusively focused on medical technology and is now the leader in mechanical thrombectomy—the removal of clots from inside blood vessels.
So far, the technology has proven its effectiveness in every clinical study it has been used in—except one. A clinical trial completed in August 2004 studied whether AngioJet treatment should be expanded to include all heart attack patients, not just those who present with large thrombus burden. The study unexpectedly showed no benefit for this large patient population. It was subsequently determined that the study itself was likely flawed because the control group had an abnormally low mortality rate. But the damage was done, as Possis stock lost 40% of its value, and the AngioJet system’s reputation suffered.
“We were trying to expand AngioJet use beyond our routine market. That was the first and only piece of negative clinical information we’ve had,” said Dutcher. “Since that time all newer, additional studies have reinforced the benefit and safety of AngioJet thrombectomy.”
Used on more than 340,000 patients, Possis developed its signature technology to treat clots in coronary and peripheral arteries, but it has recently been given clearance for use in treating venous obstructions such as deep vein thrombosis (DVT).
“We now have FDA clearance so physicians can use our products to remove blood clots from veins in the extremities. The AngioJet system is the only mechanical thrombectomy device cleared for that,” Dutcher said. “These are exciting new markets and offer a tremendous opportunity for us.”
The technology is important because there are an estimated 600,000 new cases of DVT every year in the US alone, with around 200,000 deaths caused by pulmonary embolism. Nearly two million people per year suffer a heart attack or stroke in the US, and with an aging population, these numbers are likely to grow. With so many people potentially affected by thrombosis, the AngioJet technology could help save many lives.
Free flowing future
Possis recovered from its clinical bump in the road and remained profitable. More studies countered the negative results, including a Dutch study published in 2007. The study determined when AngioJet thrombectomy is used to remove clots before drug-coated stents are placed into a coronary artery, there is a significant reduction in the number of deaths, repeat heart attacks, and stent-related clots. AngioJet’s reputation in treating coronary patients has largely been restored. The trick for Dutcher now is to switch from recovery mode into a growth phase and increase the number of hospitals and physicians using Possis technology.
Helping in that goal, the new generation AngioJet Ultra Thrombectomy System was approved by the FDA in December 2006. This new model makes use of more computer technologies and provides a fast and easy setup process. The system saw its first human use in January 2007, at Mercy Hospital in Coon Rapids, Minn. In less than 12 months, more than 400 consoles have been installed in hospitals.
“Today we are stronger than we were three years ago. Not only are we growing again, but we have a stable of new products,” Dutcher said, noting Possis also repurchased $31 million of its stock during the last three years. “We invested about 18% of our revenue to come up with new catheters and new equipment, and we have significantly broadened our overall product lines.”
As the company grows, a lot of energy will go toward expanding the reach of the AngioJet system through sales and marketing efforts to doctors and hospitals, as well as continued innovation through research and acquisition. For example, in 2006 Possis invested in Rafael Medical Technologies, a company with a product called a vena cava filter which can help prevent pulmonary embolisms. The product is currently in the clinical trial stage, and Possis has the option to buy the company once it is cleared for sale in the US market. With a large direct salesforce selling Possis equipment to hospitals throughout the US, and more than 20 international distributors marketing Possis devices worldwide, Dutcher’s team is working hard to make AngioJet technology available to patients around the world.
“We have shown that patients benefit from our technology and that, for a number of procedures using our devices, hospitals can significantly reduce cost per patient compared to other therapies. We have focused most of our energy on the US market, and we’ve only penetrated about 10% of the overall opportunity, yet we are the leader,” said Dutcher. “Going forward, we will continue to invest in the future, to develop newer products which enable us to maintain our current market presence, and also to grow into new markets.”
|
